Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse (HECTOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00437307|
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : September 22, 2016
Determination of progression free survival after 12 months of FU
Determination of total survival, response and quality of life
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Topotecan||Phase 3|
In Germany there are two established therapy regimes for platin sensitive ovarian cancer: the combination of carboplatin and paclitaxel as well as the combination of carboplatin with gemcitabine. Choice of therapy is individual due to missing randomized comparisons between the regimes. Topotecan has shown good efficacy in second-line therapy of ovarian cancer as well as a good, especially, non-hematoxic toxicity profile. Several phase II-studies have demonstrated a synergistic effect of topotecan in combination with carboplatin exhibiting good efficacy and tolerability.
It shall be tested in this randomized phase III-study if the combination of topotecan and carboplatin shows improvement of progression-free survival in comparison to the standard regimes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Topotecan Plus Carboplatin im Vergleich Zur Standardtherapie (Paclitaxel Plus Carboplatin Oder Gemcitabin Plus Carboplatin) in Der Therapie Von Patientinnen Mit Platin-sensitivem Rezidivierten Epithelialen Ovarialkarzinom, Peritonealkarzinom Oder Tubenkarzinom|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||June 2015|
U.S. FDA Resources
Active Comparator: 1
Topotecan: 0,75 mg/m²/d, Tage 1-3 und Carboplatin: AUC 5 (after Cockroft and Gault formula) am Tag 3 nach Topotecan, q 21d.
Topotecan: 0,75 mg/m²/d, day 1-3, and Carboplatin: AUC 5 (after Cockroft and Gault Formula) on day 3 after Topotecan, q 21d
Other Name: Hycamtin
No Intervention: 2
Paclitaxel 175 mg/m2/d, day 1 and Carboplatin: AUC 5 (after Cockroft and Gault formula), day 1, q21d OR gemcitabine 1000 mg/m2/d, day 1 and 8 and Carboplatin AUC 4 (after Cockroft and Gault formula), day 1, q 21d.
- progression-free survival [ Time Frame: after 1 year-follow-up ]
- overall survival, efficacy and tolerability of the regimes and quality of life [ Time Frame: during study and follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437307
|Charité Campus Virchow Klinikum|
|Berlin, Germany, 13353|
|Study Chair:||Jalid Sehouli||Charité Campus Vichow Klinikum|